A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,900
- 主要终点
- Change in trough sitting diastolic blood pressure
研究概览
简要总结
The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diastolic blood pressure between 95 and 114 mm at screening and start of treatment
排除标准
- •Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
- •Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
- •Systolic blood pressure greater or equal to 180 mm Hg at start of trial
研究组 & 干预措施
3
Hydrochlorothiazide
干预措施: Hydrochlorothiazide (Drug)
1
Metoprolol Succinate + Hydrochlorothiazide
干预措施: Metoprolol Succinate (Drug)
1
Metoprolol Succinate + Hydrochlorothiazide
干预措施: Hydrochlorothiazide (Drug)
2
Metoprolol Succinate
干预措施: Metoprolol Succinate (Drug)
结局指标
主要结局
Change in trough sitting diastolic blood pressure
时间窗: 3 readings determined at 8 weeks after treatment
次要结局
- change in trough Sitting Systolic Blood pressure(3 readings determined at 8 weeks after treatment)
- change in trough Standing Systolic Blood Pressure(6 readings determined at 8 weeks after treatment)
- change in trough standing diastolic blood pressure(6 readings determined at 8 weeks after treatment)